Department of Commerce Establishes New Humanitarian License Exception for Certain Medical Devices

Maintains Broad Export Restrictions Targeting Russia’s War Machine

WASHINGTON, D.C. – Today, the U.S. Commerce Department’s Bureau of Industry and Security (BIS) published a final rule introducing the new License Exception MED, which enables delivery of humanitarian medical devices to the citizens of Russia, Belarus, and the temporarily occupied areas of Ukraine, consistent with the longstanding practice of authorizing transfers of life-saving medical devices to civilian populaces. At the same time, BIS is maintaining its sweeping restrictions on the export, reexport, or transfer (in-country) of items that could aid Russia’s brutal full-scale invasion of Ukraine.   

Specifically, License Exception MED authorizes certain exports, reexports, and transfers (in country) of the following items that are designated as EAR99 to Russia, Belarus, the temporarily occupied Crimea region of Ukraine, and the covered regions of Ukraine: low-level “medical devices” and related low-level “parts,” “components,” “accessories,” and “attachments” that are exclusively for use in or with “medical devices”.    

“This license exception only authorizes transfers of medical devices that are regularly approved through the licensing process,” said Assistant Secretary for Export Administration Thea D. Rozman Kendler. “BIS’s action ensures that we remain laser focused on degrading Russia’s military capabilities, without causing undue harm to civilians. BIS continues to align its priorities with the Global Export Control Coalition and its partners and allies as part of a unified international effort to reduce Russia’s ability to wage its brutal war of aggression on Ukraine.” 

Today’s license exception authorizes the export, reexport, and transfer (in-country) of many items that are regularly approved for export to Russia, Belarus, the temporarily occupied Crimea region of Ukraine, and the covered regions of Ukraine. This license exception will aid both U.S. exporters, whose regulatory burden will be reduced, and BIS, which will continue to focus on restricting the export, reexport, and transfer (in-country) of items that could aid Russia in its brutal full-scale invasion of Ukraine.  

A license exception is a type of authorization under the Export Administration Regulations (EAR) that allows for BIS to impose various terms and conditions that an exporter, reexporter, or transferor must meet in order to use that license exception.  License Exception MED includes terms and conditions to ensure that only those exports, reexports, and transfers (in-country) that are being regularly approved and that advance U.S. national security and foreign policy interests are those that may be approved under this new license exception.   

Additional information on BIS’s efforts to respond to Russia’s war against Ukraine is available on BIS’s website at: https://www.bis.doc.gov/index.php/policy-guidance/countryguidance/russi….

For additional information, please visit: https://bis.doc.gov.

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